Symbios Recalls GoPump Rapid Recovery System Kits Due to Flow Rate Issues
Symbios Medical Products is voluntarily recalling GoPump Rapid Recovery System kits because some units may deliver medication at excessively high flow rates.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Symbios Medical Products, Indianapolis, Indiana, is performing a voluntary recall of all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012.…"
Plain-English summary
Symbios Medical Products, LLC, of Indianapolis, Indiana, is voluntarily recalling all GoPumps found in the GoPump Rapid Recovery System kits and all GoBlock kits manufactured with flow control components assembled prior to July 2012. The recall is being expanded after the company received additional reports relating to excessively high flow rates on the 150 mL reservoir, 2 mL/hr GOPump (PN510031).
The affected products include the Part 510180 Disposable Single Infusion Pump, which is an elastomeric pump designed to deliver local anesthetic medication at a slow rate to a surgical site. These pumps are found in specific GoPump Kits, including the GoPump Kit 510201-BP, GoPump Kit 510349-BP, and GoPump Kit 510642. The recall covers 33,543 kits distributed nationwide in the United States.
The hazard associated with this recall is that the flow control components may allow the medication to be delivered at a rate higher than intended. The source text does not report any specific injuries or illnesses resulting from this defect. Consumers and healthcare providers should stop using the affected kits and contact Symbios Medical Products for instructions on how to return the product.
The recalled product
- Product
- Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, BioPatch; Go Pump Kit 510642 Disposable Single Infusion Pump, Symbios GOPump…
- Manufacturer
- Symbios Medical Products, LLC
- Category
- Medical Device — Infusion Pump
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Pump Part 510180
- Lot 12-100616 to 13-100590
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Symbios Medical Products, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Symbios Medical Products, LLC
See all →- SevereSymbios Recalls GoPump and GoBlock Kits Due to Flow Control Defects
FDA (Devices) · 2013-06-12
- SevereSymbios Medical Recalls GoPump and GoBlock Kits Due to Flow Rate Issues
FDA (Devices) · 2013-06-12
- SevereSymbios Recalls GoPump and GoBlock Kits Due to Flow Control Defects
FDA (Devices) · 2013-06-12
- CriticalSymbios Recalls GoPump and GoBlock Kits Due to High Flow Rates
FDA (Devices) · 2013-06-12
- SevereSymbios Recalls GoPump Infusion Pumps Due to High Flow Rates
FDA (Devices) · 2013-06-12
Same hazard · excessive flow rate
See all →- SevereICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues
FDA (Devices) · 2014-10-01
- SevereICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate
FDA (Devices) · 2014-10-01
- SevereICU Medical Recalls Stat 2 Flow Controllers Due to High Flow Rate Risk
FDA (Devices) · 2014-10-01
- SevereICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate Risk
FDA (Devices) · 2014-10-01
- SevereSymbios Medical Recalls GoPump and GoBlock Kits Due to Flow Control Defects
FDA (Devices) · 2013-06-12
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